Valuation of Variable Dose of Docosahexanoic Acid for the Improvement of the Parameters of Male Fertility

Male Infertility Clinical Trial

— DHA  

Official title:

Valuation of Variable Dose of Docosahexanoic Acid for the Improvement of the Parameters of Male Fertility

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02889341
• Other study ID #: 1303-SEV-00-CG
• Status: Completed
• Phase: N/A
• First received: August 4, 2016
• Last updated: August 1, 2017
• Start date: October 22, 2013
• Est. completion date: March 2017

Study information

• Verified date: December 2016
• Source: IVI Sevilla
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Sperm parameters will be examined before DHA (DHA=Docosahexanoic Acid) consumption, after one months and after 2 months taken Docosahexanoic Acid or placebo.

Description:

Prospective, randomized, double blind, placebo-controlled intervention study within individuals. Assisted reproduction unit and academic research laboratory. One hundred an eighty human semen samples from 60 infertile patients of IVI Sevilla clinic were finally included. Assessment of oxidative stress, apoptosis, lipid peroxidation, mitochondrial membrane potential, DNA fragmentation and standard sperm parameters before and after supplementation with different DHA doses (0.5, 1 and 2 g) or placebo for 1 and 3 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2017
• Est. primary completion date: May 26, 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

Inclusion criteria:

• 1 year of infertility

• > 10 mill/ml of sperms

• Motility < 60% progressive

• Morphology < 2% (WHO 2010)

Exclusion criteria:

No meeting the inclusion criteria.

Related Conditions & MeSH terms

• Infertility
• Infertility, Male
• Male Infertility

Intervention

Dietary Supplement:
• DHA

Other:
• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
IVI Sevilla

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sperm cell concentration	Measured in millions of sperm cells per ml of semen sample	Three months
Primary	Sperm cell motility	Measured in percentage of each type of motile sperm according to OMS 2010 criteria (A-D).	Three months
Primary	Sperm cell morphology	Measured in percentage of sperm cell with normal morphology according to OMS 2010 criteria.	Three